MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS 2010 ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number 2010 RACK

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of discrepant results for 2 samples from 1 patient tested for elecsys total psa immunoassay (total psa) on a elecsys 2010 analyzer.The initial total psa result from the primary tube was 13.96 ng/ml.On (b)(6) 2018 the sample was repeated from an aliquot in a standard cup with a result of 3.31 ng/ml.On (b)(6) 2018 the sample was repeated from an aliquot in a standard cup with a result of 3.70 ng/ml.The result of 3.70 ng/ml was reported outside of the laboratory where it was questioned by the physician.On (b)(6) 2018 a new sample was obtained and the initial result from the primary tube was 3.00 ng/ml.The sample from the primary tube was repeated with a result of 16.83 ng/ml.The sample was repeated from an aliquot in a standard cup with a result of 16.14 ng/ml.The sample was sent to an external laboratory using an unspecified clia method and the result was 15.26 ng/ml.The result of 15.26 ng/ml was reported outside of the laboratory.There was no allegation that an adverse event occurred.The total psa reagent lot number was 247045.The expiration date was not provided.The customer doesn't run qc every day and when qc was run, some results were outside of the acceptable range.According to the customer, no fibrin or bubbles were observed in either sample.Service was not performed on the instrument because the instrument has since been uninstalled and replaced with a cobas e 411 immunoassay analyzer.

Manufacturer Narrative

The total psa reagent expiration date was provided as "sep-2018".Calibration signals were lower than expected.Based on the data provided, a reagent issue is not suspected.A general product problem is excluded.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS 2010 ANALYZER
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7432497
• MDR Text Key: 106147109
• Report Number: 1823260-2018-01172
• Device Sequence Number: 0
• Product Code: LTJ
• Combination Product (y/n): N
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2010 RACK
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR